Mecamylamine for the Treatment of Patients With Depression and Alcohol Dependence - Full Text View

Sponsors and Collaborators:	Yale University National Alliance for Research on Schizophrenia and Depression
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00563797

Purpose

The objective of this study is to evaluate the efficacy of mecamylamine (MEC, 10 mg/day) versus placebo in reducing depressive and alcohol symptoms in patients with depression and co-morbid alcohol dependence. The researchers hypothesize that MEC will significantly reduce depressive symptoms and decrease alcohol consumption compared to placebo in patients with depression and alcohol dependence who are on a stable dose of a selective serotonin reuptake inhibitor (SSRI).

Condition	Intervention	Phase
Alcohol Dependence Depression	Drug: Mecamylamine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	Mecamylamine for the Treatment of Patients With Depression and Alcohol Dependence

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism Depression

Drug Information available for: Mecamylamine Ethanol Mecamylamine hydrochloride

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

drinking - measured using the TLFB [ Time Frame: 25 weeks ] [ Designated as safety issue: Yes ]
depression - measured using the HAMD [ Time Frame: 25 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	August 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Intervention Details:

mecamylamine 10mg/day for 12 weeks

Detailed Description:

Depression with co-morbid alcohol dependence is very prevalent and it is very costly to treat. The co occurrence of the two disorders leads to greater severity and worse long-term outcome, including suicide. Although a number of treatment strategies have been implemented for depressed patients with alcohol dependence the controversy concerning best treatment options for those patients persists. The clinical relationship between depression and alcohol dependence suggests some common mechanism underlying both disorders. It has been hypothesized that medications that block presynaptic nAChR may be effective in the treatment of alcoholism and depression. Mecamylamine (Inversine ®) is a noncompetitive, high affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Mecamylamine has never been investigated as an effective adjunct treatment for dually diagnosed patients with depression and alcohol dependence. Methods: Thirty participants with a current diagnosis of depression and alcohol dependence will be recruited for this 12-week treatment study. Fifteen participants will be randomized to mecamylamine and fifteen to placebo.

Participants will be included in the study if: they meet current DSM-IV criteria for Major Depression and Alcohol Dependence and have been on a stable SSRI dose for 2 weeks. All participants will come weekly to take their medications and complete weekly assessments. Weekly assessments will consist of questioners that will assess depressive symptoms and alcohol consumption over the entire treatment period. Significance: This study is the first to evaluate the efficacy of mecamylamine as an augmenting agent for treatment of depression and alcohol dependence.

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Individuals with the DSM-IV diagnosis of Major Depression (MD) and Alcohol Dependence (AD) (using the SCID).
Individuals who have been on a stable SSRI dose for 2 weeks.
Smokers and non-smokers (smokers are defined as smoking more than 5 cigarettes per day).
Individuals who have a history of substance dependence (other than alcohol, tobacco and cocaine) but have not met criteria for substance dependence in the past 30 days will be included (using the SCID).
Women of childbearing potential must have a negative pregnancy test and use an acceptable method of contraception.
Individuals who are able to participate psychologically and physically; give informed consent; complete the assessments; take the study medication; and otherwise participate in the trial. A post-consent test will be given to assess patient's capacity to give informed consent.

Exclusion Criteria:

Females who are pregnant or lactating.
Patients may not be taking medications thought to influence drinking behavior, including: acamprosate, disulfiram, naltrexone, or ondansetron.
Patients with significant underlying medical conditions, such as cerebral, renal, thyroid, hepatic or cardiac pathology, which in the opinion of the physician would preclude the patient from fully cooperating or be of potential harm during the course of the study.
Patients with a history of glaucoma, prostatic hypertrophy, urethral obstruction, cerebral arteriosclerosis, pyloric stenosis, or a history of hypersensitivity to mecamylamine.
Patients who meet current SCID criteria for the following major Axis I diagnosis (Posttraumatic Stress Disorders (PTSD), Bipolar Disorders, Schizophrenia and Schizophrenia-type Disorders).
Patients with a current unstable medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology (LFT more than 5 times normal, abnormal BUN and creatinine, and unmanaged hypertension with BP higher than 200/120).
Patients on pharmacological treatments for alcohol and/or nicotine dependence. (8) Patients taking bethanechol. (9) Patients at risk for suicide.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563797

Contacts

Contact: Elizabeth Ralevski, Ph.D.

203-932-5711 ext 4282

elizabeth.ralevski@yale.edu

Locations

United States, Connecticut
VA Connecticut Healthcare System	Recruiting
West Haven, Connecticut, United States, 06516
Contact: Elizabeth Ralevski, Ph.D. 203-932-5711 ext 4282 elizabeth.ralevski@yale.edu
Principal Investigator: Elizabeth Ralevski, Ph.D.

Sponsors and Collaborators

Yale University

National Alliance for Research on Schizophrenia and Depression

Investigators

Principal Investigator:

Elizabeth Ralevski, Ph.D.

Yale University

More Information

No publications provided

Responsible Party:	Yale University ( Elizabeth Ralevski )
Study ID Numbers:	HSS # ER0002
Study First Received:	November 21, 2007
Last Updated:	June 10, 2009
ClinicalTrials.gov Identifier:	NCT00563797 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

treatment
alcohol dependence
depression
mecamylamine

Study placed in the following topic categories:

Neurotransmitter Agents
Depression
Cholinergic Antagonists
Disorders of Environmental Origin
Mecamylamine
Cardiovascular Agents
Cholinergic Agents
Depressive Disorder
Antihypertensive Agents

Behavioral Symptoms
Mental Disorders
Alcoholism
Substance-Related Disorders
Mood Disorders
Alcohol-Related Disorders
Peripheral Nervous System Agents
Ethanol

Additional relevant MeSH terms:

Ganglionic Blockers
Neurotransmitter Agents
Depression
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Nicotinic Antagonists
Physiological Effects of Drugs
Disorders of Environmental Origin
Mecamylamine
Cardiovascular Agents
Cholinergic Agents
Depressive Disorder

Antihypertensive Agents
Pharmacologic Actions
Behavioral Symptoms
Autonomic Agents
Mental Disorders
Therapeutic Uses
Alcoholism
Substance-Related Disorders
Mood Disorders
Alcohol-Related Disorders
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009